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Spots Global Cancer Trial Database for Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response (IMANOL)

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Trial Identification

Brief Title: Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response (IMANOL)

Official Title: Phase II Trial Evaluating Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response.

Study ID: NCT03434158

Interventions

Olaparib

Study Description

Brief Summary: A number of important systemic therapies have been developed to treat mCRPC and have received regulatory approval and now comprise the current therapeutic landscape. Durable and complete response following first-line chemotherapy in patients with advanced PC are uncommon. Most patients will ultimately experience disease progression within 6-9 months after initial response. Optimal Second line therapy in mCRPC is not well established and several options are possible. Olaparib has demonstrated anti-tumour activity in non-comparative studies in patients with germline BReast CAncer gene (gBRCA) mutated cancers including ovarian, breast, pancreas and prostate. Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed Breast Cancer gene-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. This phase II study is developed to assess the effect of maintenance treatment with olaparib on radiologic progression free survival (rPFS) in patients with mCRPC who have received at least 6 cycles of docetaxel and achieved partial or complete response or disease stabilization according RECIST 1.1 criteria and PCWG3.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Complexo Hospitalario Universitario de Santiago, Santiago De Compostela, A Coruña, Spain

Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain

ICO L'Hospitalet, L'Hospitalet De Llobregat, Barcelona, Spain

Hospital Clínic de Barcelona, Barcelona, , Spain

Complejo Hospitalario Regional Reina Sofía, Córdoba, , Spain

Hospital Universitario 12 de Octubre, Madrid, , Spain

Fundación Instituto Valenciano de Oncología, Valencia, , Spain

Hospital Universitario i Politècnic La Fe, Valencia, , Spain

Contact Details

Name: María J Juan Fita, MD

Affiliation: Fundación Instituto Valenciano de Oncología

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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